510(k) Blood Establishment Computer Software - 2017
Software is listed by clearance date in reverse chronological order.
510(k) Number | Applicant | Device Name | Decision Date |
---|---|---|---|
BK160071 | STRATEC Biomedical UK Limited STRATEC Biomedical USA, Inc. 98 Main Street, Suite 205 Southington, CT 06489 |
Aurora Enterprise | 10/30/2017 |
BK160017 | One Lambda, Inc. 21001 Kittridge Street Canoga Park, CA 91303 |
HLA Fusion™ Software Version 4.0 | 03/08/2017 |